Table 2

Cumulative incidence risk and rates of major or CRNM bleeding*

Bleeding outcomen=1532
No. of patientsRisk (%) (95% CI†)Rate (per 100 patient-years) (95% CI‡)
Major
Gastrointestinal11§0.7 (0.4 to 1.3)3.9 (2.0 to 7.1)
Urogenital0.3 (0.1 to 0.8)NA**
Intracranial10.1 (0.0 to 0.4)NA**
Critical organ site††00NA**
All‡‡231.5 (1.0 to 2.3)8.3 (5.3 to 12.5)
CRNM§§754.9 (3.9 to 6.1)27.6 (21.7 to 34.6)
Major bleed (all) and CRNM¶¶986.4 (5.3 to 7.8)36.2 (29.4 to 44.1)
  • *Patients may have experienced more than one type of bleeding (eg, major and clinically relevant non-major) within different sites, and so these counts are not mutually exclusive. In cases where multiple bleeding episodes have been reported within the same site, the most serious episode of bleeding was classified, and this bleeding classification with its associated event date was included in the analyses. Where events were reported but with no supporting event date, the patients were excluded.

  • †95% CI calculated using binomial exact test.

  • ‡95% CI calculated using Poisson exact test.

  • §Ten patients had a bleed reported with decreased haemoglobin of ≥2 g/dL, and five required a transfusion of ≥2 units of packed red cells or whole blood (a patient could have had more than one ISTH criterion reported).

  • ¶Five patients had a bleed reported with decreased haemoglobin of ≥2 g/dL, and one required a transfusion of ≥2 units of packed red cells or whole blood (a patient could have had more than one ISTH criterion reported).

  • **Rates were not calculated where event count n ≤10.

  • ††Excluding all intracranial; bleeding events were considered to be critical if they occurred in intraspinal, intraocular, pericardial, intraarticular, intramuscular (with compartment syndrome) or retroperitoneal sites.

  • ‡‡At least one major haemorrhagic event (irrespective of the site).

  • §§At least one CRNM bleed.

  • ¶¶At least one major haemorrhagic event (irrespective of the site) and/or CRNM bleed.

  • CRNM, clinically relevant non-major; ISTH, International Society on Thrombosis and Haemostasis; NA, not applicable.